The state of the vaccines

Thanks for the input. I remember being cultured for strep back in the late ‘70’s before being treated. I don’t know how common it was, but I remember it was a nurse practitioner.

There is still overuse in animals I’m sure as well. Coinfections and secondary infections with cocktails of viral and bacterial pneumonia causing pathogens make it very difficult to determine if an antibiotic can or should be eliminated from treatment of respiratory disease. Personally, we’ve found the best way to eliminate usage of antibiotics in beef cattle is to use low stress weaning practices. Post weaning is typically the period when antibiotics are most needed for respiratory disease. Even little things you do months ahead of weaning when calves are only days old can solve many problems later on. One example is teaching young calves where food and water sources are in the pens they will be weaned in months later so the stress levels at weaning are lower. Like I’ve said before, that works for animals. Doctors can’t force behaviors on people to prevent disease and antibiotic use. LOL

Antibiotic resistance will always be a concern. But I think we’ve come a long ways in combatting it on the veterinary use side in the last 10 years. It helps that the older generations that gave a shot of penicillin to anything that looked unthrifty without any diagnosis are giving way to younger producers more likely to treat judiciously.

 

Very informative, beautifully produced (full of nice drawings and pictures), accessible to lay people, Moderna application for EUA approval by the FDA; a very good read for those who want to learn more about this mRNA vaccine:

https://www.fda.gov/media/144583/download

The meeting is happening now, and will last all day long.

This is the FDA review of Moderna's safety and efficacy data:

https://www.fda.gov/media/144585/download

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The healthcare worker who got anaphylactic reaction to the Pfizer vaccine in Alaska did not have a history of allergy. That is concerning. She needed an epinephrine drip all night long and had to spend the night in the ICU. She did recover. But this is not good. This should shift vaccine administration to hospitals only with 30-minute observation post administration, epinephrine and oxygen available. Do understand that such reaction remains rare, but it is definitely possible, as 3 cases have occurred already, 2 in the UK and one in Alaska.

 

The Moderna FDA EUA meeting is streaming live on YouTube.

 

Jesus. Some of the panelists (supposedly, top-level specialists) speak like freaking amateurs! I'm appalled at some of the objections raised, which seem to betray a misunderstanding of this whole process! Some of the panelists are trying to change the voting question; that's a no-no! Trying to qualify "for people at high risk" or "for two months" or call the vaccine "experimental" - WTF are they doing??? Either they think the benefits outweigh the risks, or the risks outweigh the benefits, and that's what needs to be ascertained for an EUA. Nothing else. That's an EUA, not a full approval. Don't these idiots know that? The chairman had to explain it to them, after 8 hours of discussion!!! So far these idiotic opinions have apparently been thwarted but now I'm a bit afraid for the outcome of the vote!

 

The very pale brunette who tallies the votes like she did last week, is really cute, LOL. Kathleen Hayes, Designated Federal Officer.

 

The Moderna vaccine was approved 20-0-1!!! Better than the Pfizer!!! Yay!!!

 

Clever, should get at least 50% of readers interested in watching now...

 

LOL Before I saw your post I just googled her for a photo but with no luck. Looks like I'm going to have to watch it

Edit : eeks maybe not. It's 8 hours long!

 

Ah, but if you are clever you can check the timestamp on CF's post and just go back that amount of time...
That's what I did and he's quite right.

 

She appears at the very end. Fast forward.

 

Found her, and yes, she is cute

 

EMA approval is expected Dec 21 for bioNtech and Jan 7 for Moderna.

 

The FDA has just issued the EUA for the Moderna vaccine. The CDC will certainly do the same by Sunday evening.

 

The EU commission, will sign of on bioNtech no later than 23 of Dec.
Its happening all over the world.

 

Excellent. I'm very curious about the efficacy data for the CoronaVac, due on December 23rd; that one may become a good alternative for the Third World.
Then, if the one-dose J&J succeeds, it will be major. We'll accomplish better control if there is an efficacious one-dose vaccine.
The Sputinik V reportedly has 90% efficacy. I wish we could trust Russian data. I hesitate in trusting them. But if it is true that the Sputinik V is indeed 90% efficacious and is safe, that one together with the CoronaVac will be good for the non-Western countries.

 

I don't know if I've mentioned it here, but there was a second allergic reaction to the Pfizer vaccine in Alaska. A male, with eye puffiness, scratchy throat, and lightheadedness. He recovered within one hour and was released. It wasn't considered anaphylaxis. The female who had a much more serious reaction also recovered, after two days in the hospital.

I figure that with these cases plus the two UK cases and looking at how many doses have been given in the UK and the USA, I guess that grossly, we're looking at one allergic reaction for each 100,000 doses. All four individuals recovered with no complications, so, this needs to be also understood. Even if the Pfizer vaccine continues to cause allergic reaction at this rate, 1 reaction out of 100,000, none fatal, is still much better than this virus that kills 1 in 50 and maims 1 in 10.

This coming week, when the Moderna vaccination campaign starts, we'll see if it will also cause serious allergic reactions. I hope not.

 

My partner and I have decided to make vaccination part of employment and further employment.
I have very good employees and I would like to keep every single one.
So now my job is to make clear no shot no job, which is several month down the road.
I would like to give all of my employees the best education about the vaccine(s), so they can make a educated decision.
But it is for them a job or no job decision in the end.
I have to say thank you to Center Field, you provide first class professional information, which has been very helpful in my task.

You are the man.

Could you please when you have the information post what is in the Moderna vaccine, as you did for the bioNtech. Have a few people with allergies, concerning medications.

 

Thanks, gnoib. Good decision regarding your employees.

Do know that the Pfizer vaccine is authorized for people aged 16 and older, while the Moderna vaccine is for people aged 18 and older. Both vaccines need to be used with caution or avoided in people with history of severe allergies (of the anaphylactic kind). So, if one of your employees has such history, please exempt the person of your requirement.

The orientation is that anaphylactic reactions to injectable medications or vaccines should trigger the concern. Simple food allergies, seasonal allergies, etc., should not prevent someone from getting these vaccines. Those who are allergic, are better off if they take the vaccine in a place where they can be monitored for 30 minutes by professional licensed nurses who have at hand stethoscopes, epi-pens, an oxygen bottle, at least some level of respiratory support, and means to transport the person rapidly to a higher level of care.

In reply to your question, The Moderna mRNA-1273 vaccine contains the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

 

As you all know, following the FDA's EUA, the CDC has voted to recommend the Moderna vaccine for people aged 18 and older (no other restrictions), and their director confirmed it so starting tomorrow morning, the Moderna vaccine can ge legally given to Americans.

We have had 6 cases of severe allergy to the Pfizer vaccine in the US and 2 in the UK.
By the time of these 8 cases, we had 556,208 people vaccinated in the US, and about 350,000 in the UK.
So, grossly 900,000 people and 8 reactions.

It is fair to say that we might encounter 1 case of severe allergic reaction for each 100,000 vaccinated people.

Those who said it is preposterous that this was not apparent in the Phase 3 trial should remember that 22,000 people received the vaccine in Pfizer's phase 3 trial (the other 22,000 received placebos) so if the incidence is 1 in 100,000, it was easily missed, with no need for conspiracies to explain it.

The Pfizer phase 3 trial was appropriate in size and not rushed. It is the rule rather than the exception that when you give a medication or vaccine to hundreds of thousands, millions of people once they hit the market, that this post-market experience uncovers reactions that weren't in the phase 3 trial. This is a NORMAL situation that shouldn't discourage people from accepting the vaccine.

Look, all 8 people who suffered the severe allergies recovered without complications.

So, 1 in 100,000 people with a non-fatal reaction that went away with no consequences.

Compare this to this virus that kills 1 in 50 people and maims 1 in 10.

No brainer. The vaccine is safer than the disease.

The CDC has established that after the 1a group of healthcare providers and nursing home residents and staff (about 24 million people), the vaccines should go next to people aged 75 and older, first responders, such as firefighters and police officers, as well as teachers, day care staff and others working in education. Corrections officers, U.S. postal workers, public transit workers and those whose jobs are essential for the food supply — from farmers to grocery store employees — are also next up to receive the vaccine. Altogether, this group includes about 49 million people.

The shots the above (Phase 1b) are not expected imminently, but they should begin in the coming weeks, depending on how quickly a sufficient number of people in Phase 1a are vaccinated. Phase 1c will include people 65 and older, and people who have two or more underlying medical conditions that predispose them for severe Covid-19.

 

Thanks for the info.
I have one person with normal allergies. She takes 3 shots per year. So she should be fine.

EMA and the EU commission have given bioNtech/Pfizer a EUA.

 

Brazilian scientists have given the first indication that the CoronaVac is efficacious. Asked if the data (which are expected to be fully revealed two days from now, on December 23rd) support the notion that the vaccine's efficacy is above the minimum required threshold of 50% for approval, the answer was Yes, but they did not further comment on what the number is. We'll learn the number on Wednesday.

 

The soap opera of the Brazilian issue with the Chinese vaccine CoronaVac despite the main Brazilian biotech Instituto Butantan having partnered with Sinovac, the Chinese maker of the CoronaVac, has had two positive developments. One, ANVISA, the Brazilian FDA, sent a delegation to China to inspect Sinovac's headquarters, production facilities and methods (ability to maintain sterile and pure production, etc.) and concluded favorably. Two, ANVISA has finally incorporated the CoronaVac into the National Immunization Program (apparently, forces of reason have prevailed over President Bolsonaro's animosity to the CoronaVac simply on grounds that it was developed by a Chinese company - not to forget that the idiot known as President Bolsonaro is a freaking anti-vaxxer), and agreed with purchasing 100 million doses of the vaccine, in case it passes their approval process. Like I have announced earlier, the results of the Brazilian phase 3 trial of the CoronaVac, already concluded, will be diffused tomorrow. Butantan scientists have already indicated that the vaccine is efficacious, without quoting numbers yet; we'll know the number tomorrow. So apparently the CoronaVac will get the greenlight in Brazil.
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While I have a lot of insider info on the above because I've developed working ties with scientists from the Butantan Institute and I've worked in Brazil numerous times in collaboration projects, I understand that most people here couldn't care less for what happens in Brazil. Still, I find it interesting to post these things here, for a closer look at how these things happen, and given certain parallels between the Brazilian government and ours - it's not for nothing that President Bolsonaro is nicknamed "The Tropical Trump." I think that Bolsonaro has managed to be even more destructive than Trump, regarding the pandemic.

 

It's interesting to follow Brazil for three reasons:

1) They have a reliable, well-trained, and ethical scientific community with a lot of experience with vaccines (the Butantan Institute was founded more than 100 years ago).
2) They are evaluating independently a large array of vaccines: the CoronaVac itself, but also the AstraZeneca, the Pfizer, the Janssen, the Sputinik V by Gamaleya, the Moderna, and the Indian Bharat Institute's.
3) They are part of the COVAX Facility, one of the pillars of the Access to Covid-19 Tools Accelerator, that is, the international equivalent of the US Government's Warp Speed Initiative. Gavi, CEPI, WHO, the Government of France, and the European Commission put together this initiative.

So, it's interesting to see what the Brazilians will say of each of these vaccines. Their approval process is actually more rigorous than the FDA's (as in, this requirement of sending delegations to the headquarters and production facilities to inspect the companies that are applying for approval). I wouldn't trust the Chinese and the Russians simply on their word, so Brazil will offer an independent (and competent) view on these other vaccines.

 

The efficacy numbers for the CoronaVac will be announced this afternoon in Brazil, 4 PM local time. That's 2 PM here. In ten minutes. Jean Gorinchteyn, Secretary of Health for the State of São Paulo, and Dimas Tadeus Covas, the director for the Instituto Butantan, will announce it in a press conference. I'm very curious.
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Darn. I logged in to my sources, and learned that the announcement has been cancelled. China asked their Brazilian partners to hold on, in order to integrate the data from Brazil with data from Indonesia and Turkey and release one set of data instead of three different numbers. Butantan had to agree, given the confidentiality agreement they have with the Chinese, who said they need 15 more days to put it all together. So, we'll only know sometime in mid-January. The Government of São Paulo, though, maintained the start date for the vaccination campaign for January 25th, so we have to assume that they know that the numbers are good.

 

Even though the Brazilians did not divulge publicly the percentage of efficacy for the CoronaVac in contractual compliance with the request from their partners Sinovac, they did file the EUA application and sent all the data to ANVISA, their FDA, and expect approval soon. This is why they maintained the start of vaccination scheduled for 1/25: the 15-day secrecy asked by Sinovac will not delay their authorization, if they earn it. They did confirm that the vaccine met the threshold established by ANVISA, which like the FDA's, is 50%.

I can only think that the efficacy is not much better than 50% which would be why Sinovac wanted the Turkey and Indonesia data first, to be added to the Brazilian data and to be divulged in bloc (maybe the numbers are better in the other two countries). Or maybe it is good but inferior to the 95% and 94.5% for the Pfizer and Moderna vaccines, respectively, and the Chinese hope to get their number higher. Say, it's 90% and they are hoping to get to 95%.

Anyway, I don't like the lack of transparency.